Biopharmaceutical justification of the creation of self-emulsifying drug delivery systems with simvastatin

The aim of the research – to conduct biopharmaceutical tests of capsules with a self-emulsifying delivery system of simvastatin to confirm the effectiveness and feasibility of introducing into the composition of self-emulsifying drug delivery systems active pharmaceutical ingredients that are difficult to dissolve in the gastric juice environment. Material and methods. Substances, excipients, reagents and materials used during research were simvastatin (India, p. DK40-2005021, 99.09 %), castor oil (Ukraine), polyethylene glycol 40 hydrogenated castor oil (India), Tween 80 (Ukraine), glycerol monostearate (Gustav Heess GmbH, Germany), polyethylene glycol 100 stearate (ERCA, Italy), hard gelatin capsules No. 3 white (China), 0.1 M hydrochloric acid solution (made from concentrated hydrochloric acid), ethanol 96 % (Ukraine), filter paper 90 mm white tape (Ukraine). The reference drug is "Simvastatin-Sandoz" (Salyutas Pharma, Germany, series LX5161). An Evolution 60S spectrophotometer (USA) was used to carry out studies by absorption spectrophotometry. Results. Preliminary study of the absorption spectra of absorption of the substance, bases, gelatin capsules, developed self-emulsifying systems and the reference drug made it possible to predict and optimize the conduct of biopharmaceutical research. The study of the release of simvastatin from the developed delivery systems and the reference drug, which was carried out at a temperature of 37 ℃ in an environment of 0.1M hydrochloric acid, showed that the introduction of simvastatin into the composition of the investigated self-emulsifying compositions allows to increase its solubility in this solvent by five times, compared to the reference drug. Conclusions. The obtained results indicate the effectiveness of the introduction of simvastatin into the composition of self-emulsifying drug delivery systems and the feasibility of using such systems to improve the solubility and accelerate the release of a poorly water-soluble active pharmaceutical ingredient into the gastric juice environment